HeartSciences 2026 Q1 Earnings Sustained Losses with 40.2% EPS Improvement

Generated by AI AgentAinvest Earnings Report Digest
Friday, Sep 12, 2025 1:02 am ET2min read
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Aime RobotAime Summary

- HeartSciences reported 40.2% reduced EPS loss ($1.58) in Q1 2026 despite $0 revenue and stable $2.05M net loss.

- FDA Breakthrough Device designation and MyoVista Insights launch marked regulatory progress for AI-ECG platform.

- Stock rose 2.45% post-earnings but fell 10.46% month-to-date, reflecting mixed investor sentiment over financial challenges.

- Company plans 2026 FDA submissions for wavECG device and ejection fraction algorithm, aiming to accelerate AI-ECG adoption.

HeartSciences reported mixed results for Q1 2026, showing a 40.2% improvement in per-share losses year-over-year despite no revenue and a net loss that remained stable at $-2.05 million. The company emphasized progress in regulatory milestones and product launches, though revenue generation remains distant.

Revenue
HeartSciences generated $1,900 in total revenue for Q1 2026, unchanged from the previous year's Q1, which reported $0. The lack of revenue reflects the early commercial stage of the company’s AI-ECG offerings.

Earnings/Net Income
The company improved its loss per share by 40.2%, narrowing the net loss to $1.58 per share in Q1 2026 from $2.64 per share in the prior-year period. However, the net loss at the company level remained flat at $-2.05 million compared to $-2.05 million in Q1 2025. This marks the fourth consecutive year of losses for HeartSciencesHSCS-- during the same quarter, underscoring ongoing financial challenges. Despite the per-share improvement, the overall financial performance remains weak.

Price Action
The stock of HeartSciences edged higher by 2.45% during the latest trading day and gained 0.30% over the past week. However, the stock has declined by 10.46% month-to-date, indicating mixed investor sentiment following the earnings release.

Post-Earnings Price Action Review
Following the earnings release, HeartSciences' stock experienced a modest near-term gain, with a 2.45% rise on the day of the report and a 0.30% weekly increase. However, the broader trend remained bearish, as the stock posted a 10.46% decline month-to-date. The mixed performance may reflect investor optimism about the company’s product milestones, tempered by continued financial underperformance and the absence of revenue.

CEO Commentary
CEO Andrew Simpson highlighted strong execution and a clear regulatory strategy, emphasizing the successful launch of MyoVista Insights and streamlined FDA submission pathways. He noted the FDA Breakthrough Device designation for the aortic stenosis algorithm as a validation of HeartSciences’ AI-ECG opportunity, reinforcing the company’s mission to modernize ECG systems and address heart disease diagnostics.

Guidance
HeartSciences expects to submit the MyoVista wavECG device under FDA 510(k) in the current calendar year and anticipate submitting its cloud-based algorithm for detecting reduced ejection fraction in H1 2026, with potential clearance later that year. The phased rollout of MyoVista Insights continues, with Phase 2 expected to launch alongside the algorithm submission. The company plans separate FDA submissions for device and software to streamline review and enable broader deployment.

Additional News
HeartSciences made significant strides in Q1 2026, achieving the FDA Breakthrough Device Designation and launching the MyoVista Insights cloud-native software platform. The platform is designed to modernize ECG management systems and serve as an AI-ECG algorithm marketplace, enabling institutions to access both HeartSciences’ and third-party algorithms. The company also announced CPT reimbursement codes for AI-ECG, approved by CMS, which are additive to standard ECG reimbursement and expected to support AI-ECG adoption. Additionally, HeartSciences updated its algorithm in response to new ASE guidelines for evaluating LVDD, leading to a revised regulatory submission strategy that includes separate FDA submissions for the device and software to accelerate review. The company also expanded its IP portfolio, securing a key U.S. patent related to ECG-based echocardiographic parameter estimation.

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